1. Field
Embodiments of the invention are directed to an apparatus and/or a method for collecting, transferring, and processing biological specimens, including collecting cells, cellular materials, and other matter suitable for use in cytology protocols and diagnostic tests.
2. Description of the Related Art
In a wide variety of diagnostic assays, the ability to separate matter, typically cells, cellular matter, and particulate matter, from a fluid can be important for the enablement of testing for the presence or absence of substances and other diagnostic materials contained in the fluid. Oftentimes, sample preparation obscures the target matter, decreasing the utility of the sample for detection and/or diagnostic analysis. Such shortcomings are particularly acute in the field of cytological examinations, where cells, cellular structures, and related components vital to useful diagnostic examination are lost during sample preparation, transport, and testing phases.
Cytological examination of a sample typically begins with obtaining a specimen or specimens of cells and related material from a host, which is typically accomplished by brushing, scraping, or swabbing a body area, as in the case of cervical, oral, and anal specimens, or by collecting body fluids such as urine, blood, or plasma, or by collecting fluids from such body areas as the bladder, vaginal cavity, anal cavity, oral cavity, chest cavity, or spinal column, or by fine needle aspiration or fine needle biopsy of those and/or other areas of the body. A significant challenge for such cytological preparations is transferring as many cells, and related materials, from the fluid, and/or body area sampled, to collection and/or processing containers and finally to slides or other devices for diagnostic analysis. Given that diagnostic accuracy of both microbiologic and cytologic assays depends heavily on microscopic examination of cells, cellular structures, and related materials, adequate sample retention and transfer to preservative or processing fluids, and ultimately to viewing platforms and devices, can be important.
Currently, biological samples and specimens are collected for liquid-based cytological examination by using various devices, such as brushes, smears, spatulas, swabs and/or other collection devices, to transfer cells, and related materials, to a transfer or preservative liquid, which is then contacted with slides or other viewing platforms or devices for diagnostic analysis. Current methods, however, suffer from poor transfer rates of such cells and related materials to the transfer or preservative liquids. Such low transfer rates can result in poor, or even complete failure of, diagnostic utility and results.
Many of the cell collection, transfer, and analysis situations mentioned above also relate to challenges faced during various cytology and related diagnostic methods such as Human Papillomavirus (HPV), GC/Chlamydia, and other reflex testing procedures and assays.
In view of the foregoing, there is a need for improved methods and devices to increase the transfer rates of cells, cellular structures, and related materials, from collection devices to transfer or preservative liquids, and ultimately then to slides or other viewing platforms or devices for useful diagnostic analysis. One of the challenges in producing useful diagnostic samples for liquid-based cytology is ensuring that a suitable amount of cells, and other specimen materials, are transferred from collection apparati to vials, or like containers, for further processing. Other challenges include potential cross-contamination of samples and loss of materials during transfer, preparation, and analysis processes. Embodiments of the present invention may mitigate those challenges.